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Health Improvement Project - Providence (HIP)

23. desember 2019 oppdatert av: Michael P. Carey, The Miriam Hospital

Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV

This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.

Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • The Miriam Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • HIV infection
  • Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load > 20 copies/mL);
  • Psychological distress (PHQ-4 score ≥ 2);
  • Recent risky sexual behavior (any unprotected sex OR > 1 sexual partner over the past 6 months)
  • Access to a telephone or cell phone

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
  • Cognitive impairment
  • Non-English speaking
  • Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
  • Enrolled in another behavioral trials
  • Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
  • Severe hearing impairment not allowing phone delivery
  • Suicidal ideation
  • Planning to move out of the area within the study period
  • Clinic provider advising against recruitment in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mindfulness training (MT)
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Atferdsmessig: Mindfulness Training (MT)
Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Aktiv komparator: Health Coaching (HC)
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Atferdsmessig: Health Coaching (HC)
The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of Intervention
Tidsramme: post-intervention, 9 to 10 weeks after baseline
Feasibility - as indicated by the number of patients attending at least 50% of sessions
post-intervention, 9 to 10 weeks after baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability of the Intervention
Tidsramme: post-intervention, 9 to 10 weeks after baseline
Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention
post-intervention, 9 to 10 weeks after baseline
Antiretroviral Medication Adherence
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Self-reported number of missed days of medication
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Self-reported Sexual Risk Behavior
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Five Facet Mindfulness Questionnaire
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Perceived Stress Scale
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Barratt Impulsiveness Scale
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Patient Health Questionnaire
Tidsramme: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome
Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Miriam Hospital

Samarbeidspartnere

National Center for Complementary and Integrative Health (NCCIH)

Etterforskere

  • Hovedetterforsker: MIchael P Carey, PhD, Centers for Behavioral and Preventive Medicine, The Miriam Hospital
  • Hovedetterforsker: Elena Salmoirago-Blotcher, MD, PhD, Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2016

Primær fullføring (Faktiske)

1. august 2018

Studiet fullført (Faktiske)

1. august 2018

Datoer for studieregistrering

Først innsendt

18. august 2016

Først innsendt som oppfylte QC-kriteriene

26. august 2016

Først lagt ut (Anslag)

1. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. desember 2019

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • R34AT008930 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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